Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Team Approach to Polypharmacy Evaluation and Reduction (TAPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562352
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Health Canada
The Labarge Optimal Aging
David Braley and Nancy Gordon Chair in Family Medicine
RxISK
Information provided by (Responsible Party):
McMaster University

Brief Summary:
In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking so many together can do more harm than good. This study will test a program focused on medication reduction involving patient, pharmacist and physician using current technology aimed at reducing the harms of polypharmacy. Reducing the risk of adverse effects from drugs or the interactions between them involves prioritizing the most important ones according to the patient's preference and stopping those which may no longer be necessary. Reducing the dose also reduces the risk of drug side effects. Patients, aged over 69 years taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, medication review with the pharmacist and then a consultation with the family doctor focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into a clinical pathway incorporating monitoring and follow up systems. This study will examine effects on patient and health relevant outcome measures as well as patients' and clinicians' experiences of the program. The results will be used to determine whether this system can be implemented as part of routine preventative care in older adults.

Condition or disease Intervention/treatment Phase
Comorbidity Medication Therapy Management Other: TAPER program Not Applicable

Detailed Description:
Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. The intervention includes initial baseline data collection from the patient including data on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with his/her family physician to discuss patient preferences for discontinuation/dose reduction. Follow up appointments will take place at one week, 3 months and 6 months (study end). Questionnaires and a semi-structured interview will take place at the 6 month appointment. After six months, the control group will be offered the intervention.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: TAPER program

The intervention arm is comprised of:

  1. Identification of medications that are appropriate for discontinuation/dose reduction.
  2. Linked pharmacist/family physician consultations with patient to discuss medication discontinuation/dose reduction.
Other: TAPER program
Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.
Other Name: Medication Discontinuation/Dose Reduction

No Intervention: Control
Standard of Care as wait list control



Primary Outcome Measures :
  1. Successful discontinuation (Difference in mean number of medications) [ Time Frame: 6 months ]
    Difference in mean number of medications per patient.


Secondary Outcome Measures :
  1. Quality of Life (EQ-5D) [ Time Frame: 6 months ]
    EQ-5D

  2. Nutritional Status (Mini Nutritional Assessment Short-Form) [ Time Frame: 6 months ]
    Mini Nutritional Assessment Short-Form;

  3. Patient experience of deprescribing (Thematic analysis of semi structured interviews) [ Time Frame: 6 months ]
    Thematic analysis of semi structured interviews

  4. Physical Functional Capacity (Manty structured validated interview) [ Time Frame: 6 months ]
    Manty structured validated interview

  5. Falls (self report number of falls) [ Time Frame: 6 months ]
    self report number of falls

  6. Adverse Events (patient self report or clinician report) [ Time Frame: 6 months ]
    patient self report or clinician report

  7. Health Resource Utilization (Number of hospital admissions and emergency dept visits) [ Time Frame: 6 months ]
    Number of hospital admissions and emergency dept visits

  8. Cognition (The Mini Mental Status Examination) [ Time Frame: 6 months ]
    The Mini Mental Status Examination

  9. Fatigue (Avlund Mob-T Scale) [ Time Frame: 6 months ]
    Avlund Mob-T Scale

  10. Patient Enablement (Patient Enablement Index) [ Time Frame: 6 months ]
    Patient Enablement Index

  11. Self-Efficacy (Stanford Self-Efficacy Scale) [ Time Frame: 6 months ]
    Stanford Self-Efficacy Scale

  12. Patient self report of change in quality of life/morbidity (Global Impression Scale) [ Time Frame: 6 months ]
    Global Impression Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 70 years of age or older
  • Participating family doctor as most responsible provider
  • Patient of McMaster Family Health Team
  • Currently taking 5 or more medications
  • Have not had a recent comprehensive medication review
  • Patient consents

Exclusion Criteria:

  • English language or cognitive skills inadequate to understand and respond to rating scales
  • Terminal illness or other circumstance precluding 13 month study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562352


Contacts
Layout table for location contacts
Contact: Dee Mangin, MBChB, DPH, FRNZC, MD 905-525-9140 ext 21219 mangind@mcmaster.ca
Contact: Larkin Lamarche, PhD 905-525-9140 ext 21224 lamarche@mcmaster.ca

Locations
Layout table for location information
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8P 1H6
Contact: Dee Mangin, MBChB, FRNZCGP, DPH    9055259140 ext 21219    parascaj@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Health Canada
The Labarge Optimal Aging
David Braley and Nancy Gordon Chair in Family Medicine
RxISK
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02562352    
Other Study ID Numbers: TAPER-001-19-Aug-15
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by McMaster University:
polypharmacy
multimorbidity
randomized controlled trial
drug discontinuation
patient preference
eHealth